Jazz/UCB drug meets endpoints in Ph III trial

US firm Jazz Pharmaceuticals and Belgium's UCB have reported that the first of two pivotal trials of sodium oxybate for the treatment of fibromyalgia achieved its primary endpoints.

The randomized, double-blind, placebo-controlled, 14-week, Phase III study included 548 adult patients with fibromyalgia randomized to one of three treatment arms: sodium oxybate 4.5g/night, sodium oxybate 6g/night or placebo. In the top-line results, 46.2% of patients on 4.5g and 39.3% on 6g reported 30% or greater reduction in pain, compared with 27.3% of those on placebo. Physical functioning and ability to perform daily tasks were significantly different from placebo for the 4.5g dose and approached significance for the 6g arm. Patients receiving sodium oxybate also reported significant improvement in fatigue at both active dosage levels, according to the company.

The sodium oxybate program also includes a second randomized, double-blind, placebo-controlled study, which is continuing at sites in the USA and Europe, with more than 90% of subjects already enrolled. Jazz anticipates submitting a New Drug Application for sodium oxybate to the US Food and Drug Administration by the end of 2009 with UCB filing in Europe shortly afterwards. UCB has the exclusive marketing and distribution rights to Jazz' drug for fibromyalgia in Europe and some other countries outside North America. Jazz currently markets the agent as Xyrem in the USA for treating narcolepsy.